Efficacy of Nalmefene in Patients With Alcohol Dependence

NCT ID: NCT00811720

Last Updated: 2013-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 598 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-11-30

Brief Summary

The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.

Detailed Description

Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the efficacy and safety of as-needed use of nalmefene 18.06 mg versus placebo in decreasing monthly Heavy Drinking Days (HDDs) and decreasing the total consumption during a period of 6 months in adult patients with alcohol dependence.

Conditions

Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

as-needed use, tablets, orally, 6 months

Nalmefene

Group Type: EXPERIMENTAL

Nalmefene

Intervention Type: DRUG

18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Interventions

Placebo

as-needed use, tablets, orally, 6 months

Intervention Type: DRUG

Nalmefene

18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Intervention Type: DRUG

Other Intervention Names

Selincro™

Eligibility Criteria

Inclusion Criteria

In- and outpatients who:

• had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - Text revision (DSM-IV-TR) criteria
• had had ≥6 HDDs in the 4 weeks preceding the Screening Visit
• had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit

Exclusion Criteria

The patient:

• had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence
• had an antisocial personality disorder
• had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)
• had a history of delirium tremens or alcohol withdrawal seizures
• reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists
• reported current or recent treatment with antipsychotics or antidepressants
• was pregnant or breast-feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

AT001

Linz, , Austria

AT004

Salzburg, , Austria

AT003

Vienna, , Austria

AT002

Vienna, , Austria

FI008

Helsinki, , Finland

FI009

Helsinki, , Finland

FI007

Järvenpää, , Finland

FI013

Kuopio, , Finland

FI004

Kuusankoski, , Finland

FI001

Mikkeli, , Finland

FI015

Oulu, , Finland

FI003

Tampere, , Finland

FI002

Tampere, , Finland

FI014

Turku, , Finland

FI011

Vantaa, , Finland

DE011

Bad Saarow, , Germany

DE016

Berlin, , Germany

DE005

Berlin, , Germany

DE002

Berlin, , Germany

DE017

Berlin, , Germany

DE008

Berlin, , Germany

DE019

Berlin, , Germany

DE003

Essen, , Germany

DE006

Hamburg, , Germany

DE001

Hamburg, , Germany

DE007

Leukersdorf, , Germany

DE003

Mannheim, , Germany

DE014

Munich, , Germany

DE010

Regensburg, , Germany

DE018

Siegen, , Germany

DE020

Wallerfing, , Germany

SE011

Gothenburg, , Sweden

SE005

Kalmar, , Sweden

SE006

Linköping, , Sweden

SE001

Malmo, , Sweden

SE004

Stockholm, , Sweden

SE002

Stockholm, , Sweden

SE008

Stockholm, , Sweden

SE009

Uppsala, , Sweden

Countries

Austria; Finland; Germany; Sweden

References

Mann K, Bladstrom A, Torup L, Gual A, van den Brink W. Extending the treatment options in alcohol dependence: a randomized controlled study of as-needed nalmefene. Biol Psychiatry. 2013 Apr 15;73(8):706-13. doi: 10.1016/j.biopsych.2012.10.020. Epub 2012 Dec 11.

Reference Type: RESULT

PMID: 23237314 (View on PubMed)

Aubin HJ, Reimer J, Nutt DJ, Bladstrom A, Torup L, Francois C, Chick J. Clinical relevance of as-needed treatment with nalmefene in alcohol-dependent patients. Eur Addict Res. 2015;21(3):160-168. doi: 10.1159/000371547. Epub 2015 Mar 31.

Reference Type: DERIVED

PMID: 25832297 (View on PubMed)

Laramee P, Brodtkorb TH, Rahhali N, Knight C, Barbosa C, Francois C, Toumi M, Daeppen JB, Rehm J. The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model. BMJ Open. 2014 Sep 16;4(9):e005376. doi: 10.1136/bmjopen-2014-005376.

Reference Type: DERIVED

PMID: 25227627 (View on PubMed)

van den Brink W, Aubin HJ, Bladstrom A, Torup L, Gual A, Mann K. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013 Sep-Oct;48(5):570-8. doi: 10.1093/alcalc/agt061. Epub 2013 Jul 19.

Reference Type: DERIVED

PMID: 23873853 (View on PubMed)

Other Identifiers

2007-002334-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12014A

Identifier Type: -

Identifier Source: org_study_id